Bacterial Endotoxins Testing Using Non-Animal Derived Reagents and Innovative Microfluidic Technology on Real World Samples: Poster Presented at PDA Week 2025.

Abstract

Annex 1 encourages pharmaceutical companies to adopt new and innovative technologies in order to streamline their manufacturing processes. As well, companies are continually looking to create more sustainable laboratories. Using microfluidics and centripetal force, a new BET platform allows for assay set up in 85% of the time it takes to set up a traditional 96-well microplate; and is fully automated. It increases efficiency and assures precise and accurate results, allowing manufacturers to meet Annex 1 and sustainability goals while remaining in full compliance with regulations to assure patient safety. Addition to Annex 1, the USP has now accepted a new chapter, USP < 86> which will allow users to implement non-animal derived reagents compared to horseshoe crab blood extract (LAL). In this session, we'll review a case study demonstrating acceptable and comparable results using traditional LAL reagents versus non-animal derived reagents on real world samples using a microfluidic platform. This will demonstrate to the audience who are looking at sustainable testing options with new technology that these reagents are suitable for use on pharmaceutical products.